Palladone SR

Hydromorphone is a prescription medication used to relieve pain.

Hydromorphone belongs to a group of drugs called narcotic analgesics. These work by changing the way that the brain and nervous system respond to pain.

This medication comes in oral solution and tablet forms and is taken up to 4 times a day.

Do not chew, divide, or break hydromorphone extended release tablets. Swallow these tablets whole.

This medication is also available in an injectable form to be given directly into a vein (IV), a muscle (IM), or under the skin (subcutaneous).

Common side effects of hydromorphone include nausea, vomiting, constipation, drowsiness, lightheadedness, anxiety, mood changes, rash, and itching.

Hydromorphone can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how hydromorphone affects you.

Hydromorphone is a prescription medication used to relieve pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take hydromorphone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The hydromorphone dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Oral:

The recommended dose range of hydromorphone oral solution for the treatment of pain is 2.5 to 10 mg every 3 to 6 hours.

The recommended dose range of hydromorphone tablets for the treatment of pain is 2 to 4 mg every 4 to 6 hours.

The recommended dose range of extended release hydromorphone tablets for the treatment of pain is 8 to 64 mg once daily.

Injectable:

The recommended dose range of hydromorphone injection into a muscle or under the skin for the treatment of pain is 1 to 2 mg every 2 to 3 hours.

The recommended dose range of hydromorphone injection into a vein for the treatment of pain is 0.2 to 1 mg every 2 to 3 hours.

Oral:

WARNING: DILAUDID ORAL LIQUID AND DILAUDID TABLETS CONTAIN HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE, OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAVE THE HIGHEST POTENTIAL FOR ABUSE AND RISK OF PRODUCING RESPIRATORY DEPRESSION. ALCOHOL, OTHER OPIOIDS AND CENTRAL NERVOUS SYSTEM DEPRESSANTS (SEDATIVE-HYPNOTICS) POTENTIATE THE RESPIRATORY DEPRESSANT EFFECTS OF HYDROMORPHONE, INCREASING THE RISK OF RESPIRATORY DEPRESSION THAT MIGHT RESULT IN DEATH.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Hydromorphone hydrochloride extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow hydromorphone hydrochloride extended-release tablets whole to avoid exposure to a potentially fatal dose of hydromorphone.

Accidental ingestion of hydromorphone hydrochloride extended-release tablets, especially in children, can result in fatal overdose of hydromorphone.

Prolonged use of hydromorphone hydrochloride extended-release tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Injectable:

WARNING: RISK OF RESPIRATORY DEPRESSION, ABUSE, AND MEDICATION ERRORS DILAUDID-HP INJECTION IS FOR USE IN OPIOID-TOLERANT PATIENTS ONLY

Do not confuse DILAUDID-HP INJECTION with standard parenteral formulations of DILAUDID or other opioids, as overdose and death could result

Hydromorphone is a potent Schedule II opioid agonist. Schedule II opioid agonists have the highest potential for abuse and risk of producing respiratory depression. Ethanol, other opioids, and other central nervous system depressants can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.

Oral:

Serious side effects have been reported with oral hydromorphone including the following:

• Rash
• Hives
• Swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Hoarseness
• Seizures
• Chest pain
• Extreme drowsiness
• Fainting

Injectable:

Serious side effects have been reported with hydromorphone injection including the following:

• Slowed or stopped breathing
• Rash
• Hives
• Swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Hoarseness
• Seizures
• Fainting

Hydromorphone can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how hydromorphone affects you.

Do not take hydromorphone if you:

• are allergic to hydromorphone or to any of its ingredients
• have respiratory depression
• have acute, severe, or uncontrolled asthma

Hydromorphone extended release tablets may only be used in patients who are opioid-tolerant.

Serious side effects have been reported with hydromorphone. See the “Hydromorphone Precautions” section.

Oral:

Common side effects of oral hydromorphone include the following:

• Nausea
• Vomiting
• Headache
• Difficulty sleeping
• Loss of appetite
• Dry mouth
• Lightheadedness
• Heavy sweating
• Muscle, back, or joint pain
• Stomach pain
• Anxiety
• Flushing
• Itching
• Depression

Injectable:

Common side effects of hydromorphone injection include the following:

• Nausea
• Vomiting
• Constipation
• Drowsiness
• Dizziness
• Lightheadedness
• Flushing
• Mood changes
• Itching
• Dry Mouth

This is not a complete list of hydromorphone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Buprenorphine (Buprenex, Butrans, in Suboxone)
• Butorphanol (Stadol)
• Ipratropium (Atrovent)
• Medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems
• Pentazocine (Talwin)

Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past 2 weeks:

• Isocarboxazid (Marplan)
• Phenelzine (Nardil)
• Selegiline (Eldepryl, Emsam, Zelapar)
• Tranylcypromine (Parnate)

This is not a complete list of hydromorphone drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Hydromorphone falls into category C. There are no well-controlled studies that have been done in pregnant women. Hydromorphone should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Hydromorphone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from hydromorphone, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Hydromorphone has the potential for addiction, abuse, and misuse. Use this medication only as prescribed.

Seek immediate medical attention if you have difficulty breathing.

Do not abruptly discontinue using extended release hydrocodone. Discuss a tapering regimen with your health care provider before you stop taking extended release hydrocodone.